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Exhibit 10.34 *** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED PUBLIC HEALTH SERVICE PATENT LICENSE AGREEMENTEXCLUSIVE COVER PAGE For PHS internal use only: Patent License Application Number: A-338-2004 Serial Number(s) of Licensed Patent(s) and/or Patent Application(s): Group I,to which Licenseeis granted non-exclusive rights in the Licensed Fields of
Use:: a) DHHS technology ref. #E-385-1986/0: Recombinant Pseudomonas
Exotoxin: Construction of an Active Immunotoxin with Low Side EffectsIssued as US
Patent 4,892,827; b) DHHS technology ref. #E-135-1989/0: Recombinant Antibody-Toxin Fusion Protein
Issued as US Patents 6,051,405, 5,863,745, and 5,696,237; and c) DHHS technology ref. #E-306-1987/0: Methods for treating malignancy and
autoimmune disorders in humans Issued as Canadian patent 1325591 and Japanese
patent 2581788; d) DHHS technology ref. #E-306-1987/1: Methods for treating malignancy and
autoimmune disorders in humans using Tac antibodies Pending as U.S. Patent
application 08/478,748; e) DHHS technology ref. #E-163-1993/0: Recombinant Disulfide-Stabilized Polypeptide
Fragments Having Binding Specificity Issued as US Patents 5,747,654, 6,147,203, and
6,558,672; and Any related foreign filed national stage applications claiming priority to such
patent applications and patents listed in I (a)-(e) above. Group II, to which Licenseeis granted exclusive rights in the Licensed Fields of
Use:: a) DHHS technology ref. #E-146-1999/0: Reduction of nonspecific animal toxicity of
immunotoxin by mutating framework repetitions of Fv to lower isoelectric point (PCT
application PCT/US01/43602) Pending as U.S. Patent Application 10/416,129; b) DHHS technology ref. #E-216-2000/2: Pegylation of Linkers Improves Antitumor
Activity and Reduces Toxicity of Immunoconjugates (PCT application PCT/US01/18503,
combining 60/211,331 and 60/213,804) Pending as US patent application 10/297,337; c) DHHS technology ref. #E-129-2001/0: Mutated anti-CD22 antibodies with increased
affinity to CD22 expressing leukemia cells pending as PCT application
PCT/US02/30316; d) DHHS technology ref. #E-046-2004/0: Mutated anti-CD22 antibodies and
immunoconjugates Pending as US patent application number 60/525,371; and
And any related foreign filed national stage applications claiming priority to such
patent applications and patents listed in II (a)-(d) above. Licensee: Genencor International, Inc. and its Affiliates Cooperative Research and Development Agreement (CRADA) Number (if applicable): n/a




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED Additional Remarks: none Public Benefit(s): Licenseeagrees, after its First Commercial Sale,to make reasonable quantities of
Licensed Product(s)or materials produced through the use of Licensed Process(es)
available on a compassionate use basis to patients in the United States, either
through the patients physician(s) and/or the medical center treating the patient.
PHSagrees that the such a commitment by Licenseeshall not create an undue
commercial burden upon Licensee, i.e., delay and/or materially affect the commercial
development of the Licensed Product(s)or Licensed Process(es); and Licenseeagrees, after its First Commercial Saleand as part of its marketing and
product promotion, to develop written educational materials (e.g., brochures,
advertisements, etc.) directed to patients and physicians in the United States
detailing the Licensed Product(s)and/or medical aspects of using the Licensed
Product(s). This Patent License Agreement, hereinafter referred to as the Agreement", consists of this Cover
Page, an attached Agreement, a Signature Page, Appendix A (List of Patent(s) and/or Patent
Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D
(Modifications), Appendix E (Benchmarks), and Appendix F (Commercial Development Plan). The
Parties to this Agreementare:  1)
    The National Institutes of Health (NIH), the Centers for Disease
Control and Prevention (CDC), or the Food and Drug Administration (FDA),
hereinafter singly or collectively referred to as PHS, agencies of the United
States Public Health Service within the Department of Health and Human Services
(DHHS); and2)
    The person, corporation, or institution identified above and/or on the
Signature Page, having offices at the address indicated on the Signature Page,
hereinafter referred to as Licensee.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED PHS PATENT LICENSE AGREEMENTEXCLUSIVE PHSand Licensee(collectively referred to herein as the Parties) agree as follows:  1.
    BACKGROUND  1.01
    In the course of conducting biomedical and behavioral research, PHS
investigators made inventions that relate to certain therapeutic compounds and
processes useful in the treatment of cancer and that may have commercial applicability.1.02
    PHSrepresents that by assignment of rights from PHSemployees and other
inventors, DHHS, on behalf of the United States Government, owns intellectual property
rights claimed in any United States and/or foreign patent applications or patents
corresponding to the assigned inventions. DHHSalso owns any tangible embodiments of
these inventions actually reduced to practice by PHS.1.03
    PHSfurther represents that the Secretary of DHHShas delegated to PHSthe
authority to enter into this Agreementfor the licensing of rights to these inventions
and that PHShas the right to grant the licenses provided herein and to perform such
other obligations as are provided in this Agreement.1.04
    PHSdesires to transfer these inventions to the private sector through
commercialization licenses to facilitate the commercial development of products and
processes for public use and benefit.1.05
    Licenseedesires to acquire commercialization rights to certain of these
inventions in order to develop processes, methods, and/or marketable products for
public use and benefit and has submitted a license application for review by PHS
outlining Licenseescapabilities and commercial expectations for the assigned
inventions.1.06
    Licenseeand PHShave entered into simultaneously herewith a collaborative
research and development agreement (CRADA) entitled Development of Anti-CD22
Immunotoxins, BL22 and HA22, as Therapeutic Agents (CRADA No. 1975) and related to the
technology licensed under this Agreement. By virtue of the CRADAand this Agreement,
the Partiesintend to vest in Licenseea license in rights owned and/or controlled by
PHSthat are relevant and/or necessary to the treatment of cancer with therapeutic and
diagnostic compounds related to BL-22 and other CD-22 binding therapeutics developed by
the National Cancer Institute, as defined in the Licensed Field of Use.  2.
    DEFINITIONS  2.01
    Affiliatesmeans any corporation or business entity that, directly or
indirectly, through one or more intermediaries, controls, is controlled by, or is under
common control with Licensee. For the purposes of this definition, control shall mean
the possession, direct or indirect, of the power to cause the direction of the
management and policies of then corporation or business entity, whether through
ownership of fifty percent (50%) or more of the voting securities of such corporation
or business entity, by contract or otherwise.Benchmarksmean the performance milestones that are set forth in Appendix E.2.02
    Commercial Development Planmeans the written commercialization plan attached
as Appendix F.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  2.03
    Expanded Accessshall mean any procedures, such as compassionate use,
parallel track, and treatment protocols that distribute drugs to patients who are
failing on currently available treatments for their condition and also are unable to
participate in ongoing clinical trials.2.04
    First Commercial Salemeans the initial transfer after FDA approval, by or on
behalf of Licenseeor its sublicensees of Licensed Productsto a Third Partyin an
arms-length transaction or the initial practice after FDA approval, of a Licensed
Processby or on behalf of Licenseeor its sublicensees to manufacture Licensed
Productsin exchange for cash or some equivalent to which value can be assigned for the
purpose of determining Net Sales.2.05
    Governmentmeans the Federal Government of the United States of America.2.06
    Licensed Fields of Usemeans the fields of use identified in Appendix B.2.07
    Licensed Patent Rightsshall mean:  a)
    Patent applications (including provisional
patent applications and PCT patent applications) and/or patents
listed in Appendix A, all divisions and continuations of these
applications, all patents issuing from such applications,
divisions, and continuations, and any reissues, reexaminations,
extensions of all such patents, and all foreign counterparts
thereof; andb)
    to the extent that the following contain one or
more claims required for or commercially desirable for the
practice of the invention or inventions disclosed in a) above:
i) continuations-in-part of a) above; ii) all divisions and
continuations of these continuations-in-part; iii) all patents
issuing from such continuations-in-part, divisions, and
continuations; iv) priority patent application(s) of a) above;
v) any reissues, reexaminations, and extensions of all such
patents; and vi) all foreign equivalents corresponding to any
of the applications and/or patents recited in this paragraph
2.07(b). A patent application or patent shall notfall into subsection (b) above and
shall not be a Licensed Patent Rightmerely due to the fact that such patent
or patent application claims priority to an application or patent falling
under subsection (a) above, and shall notinclude (b) above to the extent
that they contain one or more claims directed to new matter which is not the
subject matter disclosed in (a) above.  2.08
    Licensed Process(es)means (a) processes which, in the course of being
practiced, would be within the scope of one or more Valid Claimsof the Licensed Patent
Rights,or (b) where the manufacture, use, sale, or importation of products produced
practicing such processes would be within the scope of one or more Valid Claimsof the
Licensed Patent Rights.2.09
    Licensed Product(s)means tangible materials which, in the course of
manufacture, use, sale, or importation thereof, would be within the scope of one or
more Valid Claimsof the Licensed Patent Rights.2.10
    Licensed Territorymeans the geographical area identified in Appendix B.2.11
    Net Salesmeans the total gross receipts for sales of Licensed Productsor
practice of Licensed Processesby or on behalf of Licenseeor its sublicensees, and
from leasing, renting, or otherwise making Licensed Productsavailable to Third Parties
without sale or other dispositions, whether




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  invoiced or not, less; trade, quantity and cash discounts and other reasonable
rebates actually allowed; product returns, recalls, credits and allowances; packing
costs, insurance costs, freight out, and taxes; excise and/or sales taxes, tariffs,
duties, value added taxes or other governmental charges (other than income taxes)
imposed and actually paid in connection with the production, importation, sale,
delivery or use of Licensed Productsor the practice of the Licensed Processes, and
wholesaler and cash discounts in amounts customary in the trade to the extent
actually granted. No deductions shall be made for commissions paid to individuals,
whether they be with independent sales agencies or regularly employed by Licensee,
or sublicensees, and on its payroll, or for the cost of collections.Only sales of Licensed Productsor practice of Licensed Processesto persons and
entities other than Licenseeand /or its Affiliatesand/or sublicensees are to be
included in Net Sales. Sales of Licensed Productor practice of Licensed Processes
between Affiliates, Affiliatesand Licenseeand/or sublicensees and Licenseeare not
to be included within Net Salesunless such Affiliateor sublicensee is the end user
of the Licensed Productor Licensed Processand further provided that subsequent
sales from such Affiliatesor sublicensees to a non-affiliated Third Partyshall be
included within Net Sales.2.12
    Pivotal Trial shall mean a controlled study in humans of the efficacy and
safety of a Licensed Productwhich is prospectively designed to demonstrate
statistically whether such Licensed Productis effective and safe for use in a
particular indication in a manner sufficient to obtain regulatory approval to market
such Licensed Product. (i.e. Phase III or Phase II/III)2.13
    Practical Applicationmeans to manufacture in the case of a composition or
product, to practice in the case of a process or method, or to operate in the case of a
machine or system; and in each case, under such conditions as to establish that the
invention is being utilized and that its benefits are to the extent permitted by law or
Governmentregulations available to the public on reasonable terms. Practical
Application shall be achieved if Licensee[ *** ] and [ *** ], including any
[ *** ] under this Agreement.2.14
    Research Licensemeans a nontransferable, nonexclusive license to make and to
use the Licensed Productsor Licensed Processesas defined by the Licensed Patent
Rightsfor purposes of research and not for purposes of commercial manufacture or
distribution or in lieu of purchase.2.15
    Third Partymeans any entity not a Partyor an Affiliate.2.16
    Valid Claimmeans a pending or granted, unexpired claim of a Licensed Patent
Rightthat has not been held to be invalid or unenforceable by an unappealed or
unappealable judgment of a court of competent jurisdiction.  3.
    GRANT OF RIGHTS  3.01
    PHShereby grants and Licenseeaccepts, subject to the terms and conditions of
this Agreement, an exclusive license under the Group II Licensed Patent Rightsin the
Licensed Territoryto make and have made, to use and have used, to sell and have sold,
to offer to sell, and to import any Licensed Productsin the Licensed Fields of Useand
to practice and have practiced any Licensed Processesin the Licensed Fields of Use.3.02
    PHShereby grants and Licenseeaccepts, subject to the terms and conditions of
this Agreement, a non-exclusive license under the Group I Licensed Patent Rightsin the
Licensed Territoryto make and have made, to use and have used, to sell and have sold,
to offer to sell, and to import any Licensed Productsin the Licensed Fields of Useand
to practice and have practiced any Licensed Processesin the Licensed Fields of Use.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  3.03
    This Agreementconfers no license or rights by implication, estoppel, or
otherwise under any patent applications or patents of PHSother than Licensed Patent
Rightsregardless of whether such patents are dominant or subordinate to Licensed
Patent Rights.  4.
    SUBLICENSING  4.01
    Upon written approval by PHS, which approval will not be unreasonably withheld,
Licenseemay enter into sublicensing agreements under the Licensed Patent Rights. In
the event that PHSdoes not provide a written objection to Licenseewithin thirty (30)
days of receiving written notice under the preceding sentence, PHSshall be deemed to
have given its approval to the sublicense arrangement described in the notice.4.02
    Licenseeshall notify PHSregarding such sublicenses and agrees that any
sublicenses granted by it shall provide that the obligations to PHSof Paragraphs
5.01-5.04, 8.01, 12.05, and 13.07-13.09 of this Agreementshall be binding upon the
sublicensee as if it were a party to this Agreement. Licenseefurther agrees to attach
copies of these Paragraphs to all sublicense agreements. For the purposes of clarity,
it is understood that the efforts of a sublicensee shall be considered the efforts of
Licensee, including adherence to the Benchmarkscontained in this Agreement, and
substantial adherence to the Commercial Development Plancontained in this Agreement,
including any modifications thereto under this Agreement.4.03
    Any sublicenses granted by Licenseeshall provide for the termination of the
sublicense, or the conversion to a license directly between such sublicensees and PHS
upon termination of this Agreementunder Article 13. Such conversion is subject to PHS
approval and contingent upon acceptance by the sublicensee of the remaining provisions
of this Agreement.4.04
    Licenseeagrees to forward to PHSa copy of each fully executed sublicense
agreement postmarked within thirty (30) days of the execution of such agreement. To
the extent permitted by law, PHSagrees to maintain each such sublicense agreement in
confidence.  5.
    STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS  5.01
    PHSreserves on behalf of the Governmentan irrevocable, nonexclusive,
nontransferable, royalty-free license for the practice of all inventions licensed under
the Licensed Patent Rightsthroughout the world by or on behalf of the Governmentand
on behalf of any foreign government or international organization pursuant to any
existing or future treaty or agreement to which the Governmentis a signatory. Any
obligations of Licenseeto provide PHSquantities of Licensed Productsor materials
made through the Licensed Processesfor PHSresearch use shall be governed by the
CRADA. In the event that PHSdesires to obtain Licensed Productsor materials made
through Licensed Processesfor purposes outside of the CRADAor after its termination
or expiration, PHSmay request from Licenseereasonable quantities thereof and Licensee
will honor such requests to the extent commercially reasonable, provided that PHSshall
reimburse Licenseefor the cost of such materials. Any provision of materials to PHS
by Licenseeunder this Agreementwill be within Licenseesdiscretion.5.02
    Licenseeagrees that products used or sold in the United States embodying
Licensed Productsor produced through use of Licensed Processesshall be manufactured
substantially in the United States, unless a written waiver is obtained in advance from
PHS.5.03
    Licenseeacknowledges that PHSmay enter into future Cooperative Research and
Development Agreements (CRADAs) with Third Partiesunder the Federal Technology
Transfer Act of 1986 that relate to the subject matter of this Agreement. Licensee
agrees not to unreasonably deny requests for a Research Licensein the Licensed Field
of Useunder the Licensed Patent Rightsfrom such future collaborators with PHSwhen
acquiring such rights is necessary in order to make




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  a Cooperative Research and Development Agreement (CRADA) project feasible. Licensee
may request an opportunity to join as a party to the proposed Cooperative Research
and Development Agreement (Third PartyCRADA).5.04
    In addition to the reserved license of Paragraph 5.01 above, PHSreserves the
right to grant nonexclusive Research Licensesdirectly or to require Licenseeto grant
nonexclusive Research Licenseson reasonable terms. The purpose of this Research
Licenseis to encourage basic research, whether conducted at an academic or corporate
facility. In order to safeguard the Licensed Patent Rights, however, PHSshall consult
with Licenseebefore granting to commercial entities a Research Licenseor providing to
them research samples of materials made through the Licensed Processes. In no event
will PHSprovide [ *** ] that are [ *** ] or [ *** ] to [ *** ].  6.
    ROYALTIES AND REIMBURSEMENT  6.01
    Licenseeagrees to pay to PHSa noncreditable, nonrefundable license issue
royalty as set forth in Appendix C within thirty (30) days from the date that this
Agreementbecomes effective.6.02
    Licenseeagrees to pay to PHSa nonrefundable minimum annual royalty as set
forth in Appendix C. The minimum annual royalty is due and payable on January 1 of
each calendar year and may be credited against any earned royalties due for sales made
in that year. The minimum annual royalty due for the first calendar year of this
Agreementshall be prorated according to the fraction of the calendar year remaining
between the effective date of this Agreementand the next subsequent January 1.6.03
    Licenseeagrees to pay PHSearned royalties as set forth in Appendix C.6.04
    Licenseeagrees to pay PHSbenchmark royalties as set forth in Appendix C.6.05
    Licenseeagrees to pay PHSsublicensing royalties as set forth in Appendix C.6.06
    A patent or patent application licensed under this Agreementshall cease to
fall within the Licensed Patent Rightsfor the purpose of computing earned royalty
payments in any given country on the earliest of the dates that a) the application has
been abandoned and not continued, b) the patent expires or irrevocably lapses, or c)
such that no Valid Claimremains, d) the claim has been irrevocably abandoned or
disallowed or e) the claim has failed to issue within five (5) years of the first
office action from the patent office of that country, provided that such claim
subsequently issues as a claim within an issued patent, such claim shall be restored to
the Licensed Patent Rights, and then shall again be used to compute earned royalty
payments for the given country.6.07
    No multiple royalties shall be payable because any Licensed Productsor
Licensed Processesare covered by more than one of any of the Licensed Patent Rights
and/or patent rights licensed under the CRADA.6.08
    On sales of Licensed Productsmade in other than an arms-length transaction,
the value of the Net Salesattributed under this Article 6 to such a transaction shall
be that which would have been received in an arms-length transaction, based on sales
of like quantity and quality products on or about the time of such transaction.6.09
    With regard to expenses associated with the preparation, filing, prosecution,
and maintenance of all patent applications and patents included within the Licensed
Patent Rightsincurred by PHSon or after the effective date of this Agreement,
Licenseeshall [ *** ] of such expenses




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  directly to the law firm employed by PHSto handle such functions upon receipt by
Licenseeof an invoice from such law firm. However, in such event, [ *** ].6.10
    Licenseemay elect to surrender its rights in any country of the Licensed
Territoryunder any Licensed Patent Rightsupon thirty (30) days written notice to PHS
and owe no payment obligation under Article 6.10 for patent-related expenses incurred
in that country after thirty (30) days of the effective date of such written notice.6.11
    If Licenseeor sublicensee is required to pay a third party earned royalties
with respect to a Licensed Product(s)and/or Licensed Process(es)under agreements for
patent rights or other technologies which Licenseeor sublicensee, in its reasonable
judgment, determines are necessary or desirable to license or acquire with respect to
such Licensed Product, and the total royalties due to such third parties [ *** ],
Licenseemay [ *** ] such earned royalties owed to such third parties by [ *** ] due to
said third parties (prior to any reductions) from the payments owing to PHSfor such
Licensed Productunder this Article 6. Notwithstanding the foregoing provisions of
this Paragraph 6.11, in no event shall the earned royalties due to PHSbe [ *** ].  7.
    PATENT FILING, PROSECUTION, AND MAINTENANCE  7.01
    Except as otherwise provided in this Article 7, PHSagrees to take
responsibility for, but to consult with, the Licenseein the preparation, filing,
prosecution, and maintenance of any and all patent applications or patents included in
the Licensed Patent Rightsand shall furnish copies of relevant patent-related
documents to Licensee.7.02
    Upon PHSs written request, Licenseeshall assume the responsibility for the
preparation, filing, prosecution, and maintenance of any and all patent applications or
patents included in the Licensed Patent Rightsand shall on an ongoing basis promptly
furnish copies of all patent-related documents to PHS. In such event, Licenseeshall,
subject to the prior approval of PHS, select registered patent attorneys or patent
agents to provide such services on behalf of Licenseeand PHS. PHSshall provide
appropriate powers of attorney and other documents necessary to undertake such actions
to the patent attorneys or patent agents providing such services. Licenseeand its
attorneys or agents shall consult with PHSin all aspects of the preparation, filing,
prosecution and maintenance of patent applications and patents included within the
Licensed Patent Rightsand shall provide PHSsufficient opportunity to comment on any
document that Licenseeintends to file or to cause to be filed with the relevant
intellectual property or patent office. Licenseeshall be responsible for costs
associated with transferring patent prosecution responsibilities to an attorney or
agent of Licenseeschoice. Notwithstanding the above, in the event that PHSlicenses
the Licensed Patent Rightsto one or more Third Partiesin outside the Licensed Fields
of Use, Licenseeshall be responsible for a pro-rata share, based on the total number
of licensees under the Licensed Patent Rights, of the costs associated with
preparation, filing, prosecution and maintenance of each relevant patent or patent
application licensed to such Third Party.7.03
    For Licensed Patent Rightsto which Licenseehas assumed responsibility for the
preparation, filing, prosecution and maintenance thereof, at any time, PHSmay provide
Licenseewith written notice that PHSwishes to reassume control of the preparation,
filing, prosecution, and maintenance of such Licensed Patent Rights. If PHSelects to
reassume such responsibilities, Licenseeagrees to cooperate fully with PHS, its
attorneys, and agents in the preparation, filing, prosecution, and maintenance of any
and all patent applications or patents included in the Licensed Patent Rightsand to
provide PHSwith complete copies of documents or other materials necessary to undertake
such responsibilities. PHSshall be responsible for all costs associated with
transferring patent prosecution responsibilities to an attorney or
agent of PHSs
choice.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  7.04
    Each party shall promptly inform the other as to all matters that come to its
attention that may affect the preparation, filing, prosecution, or maintenance of the
Licensed Patent Rightsand shall permit each other to provide comments and suggestions
with respect to the preparation, filing, prosecution, and maintenance of Licensed
Patent Rights, which comments and suggestions shall be considered by the other party.  8.
    RECORD KEEPING  8.01
    Licenseeagrees to keep accurate and correct records of Licensed Productsmade,
used, sold, or imported and Licensed Processespracticed by Licenseeunder this
Agreement. Such records shall be appropriate to determine the amount of royalties due
PHSand shall be retained for at least five (5) years following a given reporting
period. Licenseeshall make such records available pursuant to Paragraph 8.02.8.02
    Licenseeagrees to have an audit of sales and royalties conducted by an
independent auditor upon reasonable request of PHS, but not more then once per year.
The independent auditor shall be selected by PHSfor the sole purpose of verifying
reports and confirming the accuracy of payments due hereunder. The audit shall occur
during normal business hours at a site selected by Licensee. The audit shall address,
at a minimum, the amount of gross sales by or on behalf of Licenseeduring the audit
period, terms of the license as to percentage or fixed royalty to be remitted to the
Government, the amount of royalty funds owed to the Governmentunder this Agreement,
and whether the royalty amount owed has been paid to the Governmentand is reflected in
the records of the Licensee. The audit shall also indicate the PHSlicense number,
product, and the time period being audited. A report certified by the auditor shall be
submitted promptly by the auditor directly to PHS and the Licenseeon completion, which
report shall be considered confidential information of Licensee. The accountant or
auditor shall only disclose to PHSinformation relating to the accuracy of reports and
payments made under this Agreement. If an inspection shows an underreporting or
underpayment in excess of five percent (5%) for any twelve (12) month period, then
Licenseeshall reimburse PHSfor the cost of the inspection at the time Licenseepays
the unreported royalties, including any late charges as required by Paragraph 9.08 of
this Agreement. All payments required under this Paragraph shall be due within thirty
(30) days of the date PHSprovides Licenseewith written notice of the payment due.  9.
    REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS  9.01
    Prior to signing this Agreement, Licenseehas provided to PHSthe Commercial
Development Planat Appendix F, under which Licenseeintends to bring the subject
matter of the Licensed Patent Rightsto the point of Practical Application. The
Commercial Development Planis hereby incorporated by reference into this Agreement.
Performance and Benchmarksare determined as specified in Appendix E.9.02
    Licenseeshall provide written annual reports on its product development
progress or efforts to commercialize under the Commercial Development Planfor each of
the Licensed Fields of Usewithin sixty (60) days after December 31 of each calendar
year. These progress reports shall include a description of progress towards
milestones and goals outlined in the Commercial Development Planin such detail as to
permit PHSto make a reasonable assessment of whether the goals of the Commercial
Development Planare being met.. PHSencourages Licenseeto include in these reports
information on any of Licensees public service activities that relate to the Licensed
Patent Rights. If reported progress differs from that projected in the Benchmarksor
in any substantial manner from that projected in the Commercial Development Plan,
Licenseeshall explain the reasons for such differences. In any such annual report,
Licenseemay propose amendments to the Commercial Development Plan, acceptance of which
by PHSmay not be denied unreasonably. Licenseeagrees to provide any additional
information necessary for PHSto evaluate Licensees performance of its obligations as
specified in this Agreement. Licenseemay




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  amend the Benchmarksat any time upon written consent by PHS. PHSshall not
unreasonably withhold approval of any request of Licenseeto extend the time periods
of this schedule if such request is supported by a reasonable showing by Licenseeof
diligence in its performance under the Commercial Development Planand toward
bringing the Licensed Productsto the point of Practical Applicationas defined in
37 CFR 404.3(d). Licenseeshall amend the Commercial Development Planand
Benchmarksat the request of PHSto address any Licensed Fields of Usenot
specifically addressed in the plan originally submitted.9.03
    Licenseeshall report to PHSthe dates for achieving Benchmarksspecified in
Appendix E and the First Commercial Salein each country in the Licensed Territory
within thirty (30) days of such occurrences.9.04
    Licenseeshall submit to PHSwithin sixty (60) days after each calendar year
ending December 31 a royalty report setting forth for the preceding one year period the
Net Salesand the amount of royalty accordingly due. With each such royalty report,
Licenseeshall submit payment of the earned royalties due. If no earned royalties are
due to PHSfor any reporting period, the written report shall so state. The royalty
report shall be certified as correct by an authorized officer of Licenseeand shall
include a detailed listing of all deductions made under Paragraph 2.10 to determine Net
Salesmade under Article 6 to determine royalties due.9.05
    Licenseeagrees to forward annually to PHSa copy of such reports received by
Licenseefrom its sublicensees during the preceding one year period as shall be
pertinent to a royalty accounting to PHSby Licenseefor activities under the
sublicense.9.06
    Royalties due under Article 6 shall be paid in U.S. dollars. For conversion of
foreign currency to U.S. dollars, the conversion rate shall be the average of the
exchange rate included in the calendar half-year period, as quoted in the The Wall
Street Journal, Eastern Edition. All checks and bank drafts shall be drawn on United
States banks and shall be payable, as appropriate, to NIH/Patent Licensing. All such
payments shall be sent to the following address: NIH, P.O. Box 360120, Pittsburgh, PA
15251-6120. Any loss of exchange, value, taxes, or other expenses incurred in the
transfer or conversion to U.S. dollars shall be paid entirely by Licensee. The royalty
report required by Paragraph 9.04 of this Agreementshall accompany each such payment,
and a copy of such report shall also be mailed to PHSat its address for notices
indicated on the Signature Page of this Agreement.9.07
    Licenseeshall be solely responsible for determining if any tax on royalty
income is owed outside the United States and shall pay any such tax and be responsible
for all filings with appropriate agencies of foreign governments.9.08
    Interest and penalties may be assessed by PHSon any overdue payments in
accordance with the Federal Debt Collection Act. The payment of such late charges
shall not prevent PHSfrom exercising any other rights it may have as a consequence of
the lateness of any payment.9.09
    All plans and reports required by this Article 9 and marked confidential by
Licenseeshall, to the extent permitted by law, be treated by PHSas commercial and
financial information obtained from a person and as privileged and confidential, and
any proposed disclosure of such records by the PHS under the Freedom of Information Act
(FOIA), 5 U.S.C.  552 shall be subject to the predisclosure notification
requirements of 45 CFR  5.65(d).  10.
    PERFORMANCE  10.01
    Licenseeshall use its reasonable best efforts to bring the Licensed Products
and Licensed Processesto Practical Application. Reasonable best efforts for the
purposes of this provision shall be satisfied if Licensee adheresto the Benchmarksat
Appendix E and substantially adheres




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  to the Commercial Development Plan at Appendix F. The efforts of a sublicensee
shall be considered the efforts of Licensee.10.02
    Upon the First Commercial Sale, until the expiration of this Agreement,
Licensee shall use its reasonable best efforts to make Licensed Products and Licensed
Processes reasonably accessible to the United States public.10.03
    Licenseeagrees, after itsFirst Commercial Sale, to make reasonable
quantities of Licensed Product(s) or materials produced through the use of Licensed
Process(es) available on an Expanded Accessuse basis to patients in the United
States, either through the patients physician(s) and/or the medical center treating
the patient. PHS agrees that the such a commitment by Licensee shall not create an
undue commercial burden upon Licensee, i.e., delay and/or materially affect the
commercial development of the Licensed Product(s) or Licensed
Process(es). The retail
value of the drug provided for free or at a discount through the Expanded Access
program will not exceed [ *** ]. Licenseewill not be required to pay any royalty
under this Agreementwith respect to any Licensed
Products or materials used in
Licensed Processes that are distributed through an Expanded
Access program.10.04
    Licenseeagrees, after its First Commercial Saleand as part of its marketing
and product promotion, to develop written educational materials (e.g., brochures,
advertisements, etc.) directed to patients and physicians in the United States
detailing the Licensed Product(s)and/or medical aspects of using the Licensed
Product(s).  11.
    INFRINGEMENT AND PATENT ENFORCEMENT  11.01
    PHSand Licenseeagree to notify each other promptly of each known
infringement or possible infringement of the Licensed Patent Rights, as well as any
facts which may affect the validity, scope, or enforceability of the Licensed Patent
Rightsof which either Party becomes aware.11.02
    Pursuant to this Agreementand the provisions of Chapter 29 of title 35,
United States Code, Licenseemay: a) bring suit in its own name, at its own expense,
and on its own behalf for infringement of the Licensed Patent Rightsin the Licensed
Field of Use; b) in any such suit, enjoin infringement and collect for its use,
damages, profits, and awards of whatever nature recoverable pursuant to such suit; and
c) settle any claim or suit for infringement of the Licensed Patent Rightsin the
Licensed Field of Use; provided, however, that PHSand appropriate Government
authorities shall have the first right to take such actions. If Licenseedesires to
initiate a suit for patent infringement, Licenseeshall notify PHSin writing. If PHS
does not notify Licenseeof its intent to pursue legal action within ninety (90) days
of such notice, Licenseewill be free to initiate suit. PHSshall have a continuing
right to intervene in such suit. Licenseeshall take no action to compel the
Governmenteither to initiate or to join in any such suit for patent infringement.
Licenseemay request the Governmentto initiate or join in any such suit if necessary
to avoid dismissal of the suit. Should the Governmentbe made a party to any such suit
pursuant to Licenseesrequest or motion, Licenseeshall reimburse the Governmentfor
any costs, expenses, or fees which the Governmentincurs as a result of such motion,
including any and all costs incurred by the Governmentin opposing any such motion,
provided that Licenseeshall have no further obligation to reimburse PHSor the
Governmentfor participation in such action. In all cases, Licenseeagrees to keep PHS
reasonably apprised of the status and progress of any litigation in which it is
involved regarding the Licensed Patent Rights. Before Licenseecommences an
infringement action, Licenseeshall notify PHSand give careful consideration to the
views of PHSand to any potential effects of the litigation on the public health in
deciding whether to bring suit.11.03
    In the event that a declaratory judgment action alleging invalidity or
non-infringement of any of the Licensed Patent Rightsshall be brought against Licensee
or raised by way of counterclaim or affirmative defense in an infringement suit brought
by Licensee, PHSor the Governmentunder Paragraph 11.02, pursuant to this Agreement
and the provisions of Chapter 29 of Title 35, United




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  States Code or other statutes, Licenseemay: a) defend the suit in its own name, at
its own expense, and on its own behalf; b) in any such suit, seek to file any
appropriate counterclaim, including to enjoin infringement and to collect for its
use, damages, profits, and awards of whatever nature pursuant to such suit; and c)
settle any claim or suit for declaratory judgment involving the Licensed Patent
Rights;provided, however, that PHSand appropriate Governmentauthorities shall
have the first right to take such actions and shall have a continuing right to
intervene in such suit. If PHSdoes not notify Licenseeof its intent to respond to
the legal action within ninety (90) days or such shorter time as may be set for
response by the tribunal adjudicating such action, Licenseewill be free to do so.
Licenseeshall take no action to compel the Governmenteither to initiate or to join
in any such declaratory judgment action. Licenseemay request the Governmentto
initiate or to join any such suit if necessary to avoid dismissal of the suit.
Should the Governmentbe made a party to any such suit by motion or any other action
of Licensee, Licenseeshall reimburse the Governmentfor any costs, expenses, or
fees which the Governmentincurs as a result of such motion or other action,
provided that Licenseeshall have no further obligation to reimburse PHSor the
Governmentfor participation in such action. If Licenseeelects not to defend
against such declaratory judgment action, PHS, at its option, may do so at its own
expense. In all cases, Licenseeagrees to keep PHSreasonably apprised of the
status and progress of any litigation. Before Licenseecommences an infringement
action, Licenseeshall notify PHSand give careful consideration to the views of PHS
and to any potential effects of the litigation on the public health in deciding
whether to bring suit.11.04
    In any action taken by Licenseeunder Paragraphs 11.02 or 11.03, the expenses
including costs, fees, attorney fees, and disbursements, shall be paid by Licensee.
The value of any recovery made by Licenseethrough court judgment or settlement, less
applicable legal fees, shall be treated as Net Salesand subject to earned royalties.11.05
    PHSshall cooperate fully with Licenseein connection with any action under
Paragraphs 11.02 or 11.03. PHSagrees promptly to provide access to all necessary
documents and to render reasonable assistance in response to a request by Licensee.  12.
    NEGATION OF WARRANTIES AND INDEMNIFICATION  12.01
    PHSoffers no warranties other than those specified in Article 1.12.02
    PHSdoes not warrant the validity of the Licensed Patent Rightsand makes no
representations whatsoever with regard to the scope of the Licensed Patent Rights, or
that the Licensed Patent Rightsmay be exploited without infringing other patents or
other intellectual property rights of third parties.12.03
    PHSMAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED
PATENT RIGHTSOR TANGIBLE MATERIALS RELATED THERETO.12.04
    PHSdoes not represent that it will commence legal actions against third
parties infringing the Licensed Patent Rights.12.05
    [ *** ] shall indemnify and hold [ *** ] harmless from and against all
liability, demands, damages, expenses, and losses, including but not limited to death,
personal injury, illness, or property damage in connection with or arising out of: a)
the [ *** ]; or b) the [ *** ]. [ *** ] agrees to maintain a [ *** ] consistent with [
*** ]. The indemnification in this paragraph shall not extend to [ *** ].




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  13.
    TERM, TERMINATION, AND MODIFICATION OF RIGHTS  13.01
    This Agreementis effective when signed by all parties and shall extend to the
expiration of the last to expire of the Licensed Patent Rightsunless sooner terminated
as provided in this Article 13.13.02
    In the event that Licenseeis in default in the performance of any material
obligations under this Agreement, including but not limited to the obligations listed
in Article 13.05, and if the default has not been remedied within ninety (90) days
after the date of notice in writing of such default, PHSmay terminate this Agreement
in whole or in part by written notice and pursue outstanding amounts owed through
procedures provided by the Federal Debt Collection Act.13.03
    In the event that Licenseebecomes insolvent, files a petition in bankruptcy,
has such a petition filed against it, or receives notice of a third partys intention
to file an involuntary petition in bankruptcy, Licenseeshall immediately notify PHSin
writing. Furthermore, PHSshall have the right to terminate this Agreementimmediately
upon Licensees receipt of written notice.13.04
    Licenseeshall have a unilateral right to terminate this Agreementand/or any
licenses in any country or territory by giving PHSsixty (60) days written notice to
that effect.13.05
    PHSshall specifically have the right to terminate or modify, at its option,
this Agreement, if PHSdetermines in good faith that the Licensee: 1) is not [ *** ]
executing the Commercial Development Plansubmitted with its request for a license, as
modified pursuant to Paragraph 9.02, and the Licenseecannot otherwise demonstrate to
PHSs satisfaction that the Licenseehas taken, or can be expected to take within a
reasonable time, effective steps to achieve Practical Applicationof the Licensed
Productsor Licensed Processes; 2) has not achieved the Benchmarksas may be modified
under Paragraph 9.02 or Article 10; 3) is not keeping Licensed Productsor Licensed
Processesreasonably available, in accordance with the Commercial Development Plan, as
modified pursuant to Paragraph 9.02, to the public after First Commercial Sale; 4) has
not reasonably satisfied, and is not capable of reasonably satisfying, significant
unmet health and safety needs identified in the Commercial Development Plan, as
modified pursuant to Paragraph 9.02 or 5) cannot reasonably justify a failure to comply
with the domestic production requirement of Paragraph 5.02 unless waived. PHSshall
specifically have the right to terminate or modify, at its option, this Agreement, if
PHSdetermines in good faith that the Licensee: 1) has willfully made a false statement
of, or willfully omitted, a fact that PHScan establish was material to their decision
to grant or maintain the license provided herein, either in the license application or
in any report required by the license Agreement; or 2) has committed a material breach
of a covenant or agreement contained in the license that is not remedied within ninety
(90) days after the date of notice of such default; . In making any determination
under this Paragraph 13.05, PHSwill take into account the normal course of such
commercial development programs conducted with sound and reasonable business practices
and judgment, the annual reports submitted by Licenseeand modifications, if any, under
Paragraph 9.02 and discussions between the Partiesregarding modifications of
Benchmarksand/or the Commercial Development Planas provided for in Paragraph 9.02.
Prior to invoking this right, PHSshall give written notice to Licenseeproviding
Licenseespecific notice of, and a ninety (90) day opportunity to respond to, PHSs
concerns . If Licenseefails to alleviate PHSs concerns ) or fails to initiate
corrective action to PHSs satisfaction, PHSmay terminate this Agreement, in whole or
in part at its sole option.13.06
    When the public health and safety so require, and after written notice to
Licenseeproviding Licenseea sixty (60) day opportunity to respond, PHSshall have the
right to require Licenseeto grant sublicenses to responsible applicants, on reasonable
terms, in any Licensed Fields of Useunder the Licensed Patent Rights, unless Licensee
can reasonably demonstrate that the granting of the sublicense would not materially
increase the availability to the public of the subject matter




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  of the Licensed Patent Rights. PHSwill not require the granting of a sublicense
unless the responsible applicant has first negotiated in good faith with Licensee.13.07
    PHSreserves the right according to 35 U.S.C. ' 209(d)(3) to terminate
or modify this Agreementif it is determined that such action is necessary to meet
requirements for public use specified by federal regulations issued after the date of
the license and such requirements are not reasonably satisfied by Licensee.13.08
    Within thirty (30) days of receipt of written notice of PHSs unilateral
decision to modify or terminate this Agreement, Licenseemay, consistent with the
provisions of 37 CFR 404.11, appeal the decision by written submission to the
designated PHSofficial. The decision of the designated PHSofficial shall be the
final agency decision. Licenseemay thereafter exercise any and all administrative or
judicial remedies that may be available.13.09
    Within ninety (90) days of expiration or termination of this Agreementunder
this Article 13, a final report shall be submitted by Licensee. Any royalty payments,
including those incurred but not yet paid (such as the full minimum annual royalty),
and those related to patent expenses, due to PHSshall become immediately due and
payable upon termination or expiration. If terminated under this Article 13,
sublicensees may elect to convert their sublicenses to direct licenses with PHS
pursuant to Paragraph 4.03. Unless otherwise specifically provided for under this
Agreement, upon termination of this Agreement, Licenseemay sell or otherwise transfer
such existing inventory of Licensed Productsas are covered by the Licensed Patent
Rightssubject to such sales being considered Net Saleshereunder and subject to
payment of the applicable royalty hereunder, within ninety (90) days of termination of
this Agreement. Upon expiration, Licenseeshall have no further obligations to PHS
under this Agreement.13.10
    In the event that Licenseefails to meet a Benchmarkfor either BL22 or HA22
but continues to meet Benchmarksfor the other of said BL22 or HA22, PHSagrees that
such failure will result only in a right to terminate the Agreementunder Paragraph
13.05 with respect to the product for which a Benchmarkis not achieved and not to the
entirety of the Licensed Field of Use.  14.
    GENERAL PROVISIONS  14.01
    Neither Partymay waive or release any of its rights or interests in this
Agreementexcept in writing. The failure of either Partyto assert a right hereunder
or to insist upon compliance with any term or condition of this Agreementshall not
constitute a waiver of that right by that Partyor excuse a similar subsequent failure
to perform any such term or condition by other Party.14.02
    This Agreementconstitutes the entire agreement between the Parties relating
to the subject matter of the Licensed Patent Rights, and all prior negotiations,
representations, agreements, and understandings are merged into, extinguished by, and
completely expressed by this Agreement.14.03
    The provisions of this Agreementare severable, and in the event that any
provision of this Agreementshall be determined to be invalid or unenforceable under
any controlling body of law, such determination shall not in any way affect the
validity or enforceability of the remaining provisions of this Agreement.14.04
    If either Party desires a modification to this Agreement, the Parties shall,
upon reasonable notice of the proposed modification by the Party desiring the change,
confer in good faith to determine the desirability of such modification. No
modification will be effective until a written amendment is signed by the signatories
to this Agreementor their designees.14.05
    The construction, validity, performance, and effect of this Agreementshall be
governed by Federal law as applied by the Federal courts in the District of Columbia.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  14.06
    All notices required or permitted by this Agreementshall be given by prepaid,
first class, registered or certified mail or by an express/overnight delivery service
provided by a commercial carrier, properly addressed to the other Party at the address
designated on the following Signature Page, or to such other address as may be
designated in writing by such other Party. Notices shall be considered timely if such
notices are received on or before the established deadline date or sent on or before
the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a
commercial carrier. Parties should request a legibly dated U.S. Postal Service
postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal
Service. Private metered postmarks shall not be acceptable as proof of timely mailing.14.07
    This Agreementshall not be assigned by Licenseeexcept: a) with the prior
written consent of PHS, such consent not to be withheld unreasonably; or b) as part of
a sale or transfer of a part of or substantially all of the business of Licensee
relating to operations which concern this Agreement,including any transfer in the form
of a sale to a third party of the right to develop or commercialize a therapeutic or
diagnostic that falls within the Agreement. Licenseeshall notify PHSwithin ten (10)
days of any assignment of this Agreementby Licensee.14.08
    Licenseeagrees in its use of any PHS-supplied materials to comply with all
applicable statutes, regulations, and guidelines, including PHSand DHHSregulations
and guidelines. Licenseeagrees not to use the materials provided by PHSfor research
involving human subjects or clinical trials in the United States without complying with
21 CFR Part 50 and 45 CFR Part 46. Licenseeagrees not to use the materials for
research involving human subjects or clinical trials outside of the United States
without notifying PHS, in writing, of such research or trials and complying with the
applicable regulations of the appropriate national control authorities. Written
notification to PHSof research involving human subjects or clinical trials outside of
the United States shall be given no later than sixty (60) days prior to commencement of
such research or trials.14.09
    Licenseeacknowledges that it is subject to and agrees to abide by the United
States laws and regulations (including the Export Administration Act of 1979 and Arms
Export Control Act) controlling the export of technical data, computer software,
laboratory prototypes, biological material, and other commodities. The transfer of
such items may require a license from the cognizant Agency of the U.S. Governmentor
written assurances by Licenseethat it shall not export such items to certain foreign
countries without prior approval of such agency. PHSneither represents that a license
is or is not required or that, if required, it shall be issued.14.10
    Licenseeagrees to mark the Licensed Productsor their packaging sold in the
United States with all applicable U.S. patent numbers and similarly to indicate Patent
Pending status as necessary to preserve rights to damages of PHSand/or Licenseein
enforcement actions against future infringing third parties. All Licensed Products
manufactured in, shipped to, or sold in other countries shall be marked in such a
manner as to preserve PHSpatent rights in such countries.14.11
    By entering into this Agreement, PHSdoes not directly or indirectly endorse
any product or service provided, or to be provided, by Licenseewhether directly or
indirectly related to this Agreement. Licenseeshall not state or imply that this
Agreementis an endorsement by the Government, PHS, any other Governmentorganizational
unit, or any Governmentemployee. Additionally, Licenseeshall not use the names of
NIH, CDC, PHS, or DHHSor the Governmentor their employees in any advertising,
promotional, or sales literature without the prior written consent of PHS, except as
required for compliance with any statute, rule or regulatory or listing agency
requirement.14.12
    The Parties agree to attempt to settle amicably any controversy or claim
arising under this Agreementor a breach of this Agreement, except for appeals of
modifications or termination decisions provided for in Article 13. Licenseeagrees
first to appeal any such unsettled claims or




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  controversies to the designated PHSofficial, or designee, whose decision shall be
considered the final agency decision. Thereafter, Licenseemay exercise any
administrative or judicial remedies that may be available.14.13
    Nothing relating to the grant of a license, nor the grant itself, shall be
construed to confer upon any person any immunity from or defenses under the antitrust
laws or from a charge of patent misuse, and the acquisition and use of rights pursuant
to 37 CFR Part 404 shall not be immunized from the operation of state or Federal law by
reason of the source of the grant.14.14
    Paragraphs 4.03, 8.01, 9.05-9.07, 12.01-12.05, 13.08, 13.09, and 14.12 of this
Agreementshall survive termination of this Agreement. SIGNATURES BEGIN ON NEXT PAGE




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED PHS PATENT LICENSE AGREEMENTEXCLUSIVE SIGNATURE PAGE For PHS: /s/ Steven M. Ferguson
    
    November 29, 2004Steven M. Ferguson
    
    DateDirector, Division of Technology Development and TransferOffice of Technology TransferNational Institutes of HealthMailing Address for Notices:
 Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A. For Licensee(Upon, information and belief, the undersigned expressly certifies or affirms that the
contents of any statements of Licenseemade or referred to in this document are truthful and
accurate.): by: /s/ Mark A. Goldsmith
    
    December 7, 2004Signature of Authorized Official
    
    DateMark A. GoldsmithPrinted NameSenior Vice President, Health CareTitle
 Official and Mailing Address for Notices:Genencor International, Inc.925 Page Mill RoadPalo Alto, CA 94304-1013
 Any false or misleading statements made, presented, or submitted to the Government, including any
relevant omissions, under this Agreementand during the course of negotiation of this Agreementare
subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C.
 3801-3812 (civil liability) and 18 U.S.C.  1001 (criminal liability including
fine(s) and/or imprisonment).




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX APatent(s) or Patent Application(s) Patent(s) or Patent Application(s): Group I,to which Licenseeis granted non-exclusive rights in the Licensed Fields of Use:: a) DHHS technology ref. #E-385-1986/0: Recombinant Pseudomonas Exotoxin: Construction
of an Active Immunotoxin with Low Side EffectsIssued as US Patent 4,892,827; b) DHHS technology ref. #E-135-1989/0: Recombinant Antibody-Toxin Fusion Protein Issued as
US Patents 6,051,405, 5,863,745, and 5,696,237; and c) DHHS technology ref. #E-306-1987/0: Methods for treating malignancy and autoimmune
disorders in humans Issued as Canadian patent 1325591 and Japanese patent 2581788; d) DHHS technology ref. #E-306-1987/1: Methods for treating malignancy and autoimmune
disorders in humans using Tac antibodies Pending as U.S. Patent application 08/478,748; e) DHHS technology ref. #E-163-1993/0: Recombinant Disulfide-Stabilized Polypeptide
Fragments Having Binding Specificity Issued as US Patents 5,747,654, 6,147,203, and
6,558,672; and Any related foreign filed national stage applications claiming priority to such patent
applications and patents listed in I (a)-(e) above. Group II, to which Licenseeis granted exclusive rights in the Licensed Fields of Use:: a) DHHS technology ref. #E-146-1999/0: Reduction of nonspecific animal toxicity of
immunotoxin by mutating framework repetitions of Fv to lower isoelectric point (PCT
application PCT/US01/43602) Pending as U.S. Patent Application 10/416,129; b) DHHS technology ref. #E-216-2000/2: Pegylation of Linkers Improves Antitumor Activity
and Reduces Toxicity of Immunoconjugates (PCT application PCT/US01/18503, combining
60/211,331 and 60/213,804) Pending as US patent application 10/297,337; c) DHHS technology ref. #E-129-2001/0: Mutated anti-CD22 antibodies with increased affinity
to CD22 expressing leukemia cells pending as PCT application PCT/US02/30316; d) DHHS technology ref. #E-046-2004/0: Mutated anti-CD22 antibodies and immunoconjugates
Pending as US patent application number 60/525,371; and Any related foreign filed national stage applications claiming priority to such patent applications
and patents listed in II (a)-(d) above.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX BLicensed Fields of Use and Territory Licensed Fields of Use: Use of the BL22 and HA22 and variants thereof as claimed in the Licensed Patent Rightsfor [
*** ]. Licensed Territory: Worldwide




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX CRoyalties Royalties: I. Licenseeagrees to pay to PHSa noncreditable, nonrefundable license issue royalty in the amount
of [ *** ]. II. Licenseeagrees to pay to PHSa nonrefundable minimum annual royalty in the amount of [ *** ],
with the understanding that payments made under any existing CRADA with NCI relating the BL22 or
HA22 in that same year are fully creditable towards this minimum annual royalty. III. Licenseeagrees to pay PHSearned royalties on Net Salesby or on behalf of Licenseeand its
sublicensees as follows: [ *** ] of Net Salesof BL-22 and [ *** ] of Net Salesof HA-22, subject to Paragraph 6.11. IV. Licenseeagrees to pay PHSbenchmark royalties as follows within thirty (30) days of achieving
said Benchmark: BL22 Benchmarks  Hairy Cell Leukemia (HCL) First patient dosing in first Pivotal Trial
in humans, anywhere in the Licensed Territory,
utilizing and/or directed to Licensed Product(s)
and/or Licensed Process(es)anywhere in theLicensed Territory
    
    [ *** ]First BLA/NDA filing
    
    [ *** ]First Commercial Saleof BL22 to treat HCL
anywhere in the Licensed Territory,utilizing
and/or directed to Licensed Product(s)and/or
Licensed Process(es)anywhere in the Licensed
Territory
    
    [ *** ]
 BL22 Benchmarks  Indication(s) other than HCL Licenseeagrees to amend its Commercial Development Planand Benchmarksto include the use
of BL22 to treat hematologic indication(s) other than HCL, should Licenseecontemplate such
clinical development. PHSagrees to accept such changes to Licensees Commercial
Development Plan, subject to Paragraph 9.02. PHSfurther agrees to provide Licenseewith
proposed benchmark royalties for such indication(s) and to negotiate the proposed benchmark
royalties with Licenseein good faith. HA22 Benchmarks  All Milestones are Per Indication and Payable Only Once Per Indication First
patient dosing in a Phase I clinical trial
in humans, anywhere in the Licensed Territory,
utilizing and/or directed to Licensed Product(s)
and/or Licensed Process(es)anywhere in the
Licensed Territory
    
    [ *** ]First patient dosing in a Pivotal Trial
in humans, anywhere in the Licensed Territory,
utilizing and/or directed to Licensed Product(s)




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED and/or Licensed Process(es)anywhere in theLicensed Territory
    
    [ *** ]Filing of BLA/NDA
    
    [ *** ]BLA/NDA Approval for Marketing
    
    [ *** ]First Commercial Saleof HA22 associated
with each NDA filing anywhere in the
Licensed Territory,utilizing and/or directed
to Licensed Product(s)and/or Licensed
Process(es)anywhere in the Licensed Territory
    
    [ *** ]
 V. Sublicense Royalties  (a)
    Licenseeagrees to pay PHSa Sublicense Royalty based on fees received by
Licenseepursuant to a sublicense of the rights granted Licenseein this Agreement,
where such fees are not any of (a) payments for royalties received from a sublicensee
related to the sale of Licensed Productssubject to this Agreement; (b) payments
received as an advance creditable against earned royalties; (c) payments received as
compensation for research and development costs incurred subsequent to the effective
date of the sublicense; and (d) payments received as an equity investment in Licensee.For any sublicense granted [ *** ], the Sublicense Royalty shall be [ *** ]. For
any sublicense granted [ *** ], the Sublicense Royalty shall be [ *** ]. For any
sublicenses granted [ *** ], the Sublicense Royalty shall be [ *** ].(b)
    Licenseemay contract with a sublicensee such that said sublicensee is
responsible for payment to Licenseeof a milestone or benchmark payment for occurrence
of an event that would cause Licenseeto be responsible for a payment to PHSunder this
Agreementpursuant to Paragraph 6.04. In such case, only that part of such payment
that is received by Licenseethat exceeds the amount due for a specific benchmark under
Paragraph 6.04 shall be subject to a Sublicense Royalty under subsection (a) above.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX DModifications PHSand Licenseeagree to the following modifications to the Articles and Paragraphs of this
Agreement: All modifications to the Agreementare contained within the body of the Agreement.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX EBenchmarks and Performance Licenseeagrees to the following Benchmarksfor its performance under this Agreementand, within
thirty (30) days of achieving a Benchmark, shall notify PHSthat the Benchmarkhas been achieved. BL22 Therapeutic Benchmarks: First Pivotal clinical trial patient dosing
    
    on or before [ *** ]NDA /BLA filing
    
    on or before [ *** ]First Commercial Sale
    
    on or before [ *** ]
 HA22 Therapeutic Benchmarks First Phase I trial patient dosing
    
    on or before [ *** ]First Pivotal trial patient dosing
    
    on or before [ *** ]NDA /BLA filing
    
    on or before [ *** ]First Commercial Sale
    
    on or before [ *** ]
 Licenseehas also indicated in its Application for License to Public Health Service Inventions,
received by PHSon July 6, 2004, that pre-clinical studies might be undertaken in the field of [
*** ]. Should Licenseedesire to amend this Agreementto include such field of use, Licenseeshall
submit to PHSa complete Commercial Development Planand Benchmarksrelating to such field of use.
PHSagrees to consider, in good faith, an amendment to the Agreementto include such field of
use.




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED APPENDIX FCommercial Development Plan BL22 Early Clinical Development Plan
Since BL22 is in [ *** ] for [ *** ] no further [ *** ]. If, following discussion with FDA, [ ***
], Genencor will [ *** ]. BL22 is currently in [ *** ] at [ *** ]. A [ *** ] is also underway. Genencor will assume [ ***
] and [ *** ]. [ *** ] is the sole site for these studies. Sponsorship of [ *** ], which is
currently held by [ *** ], will transfer to Genencor. BL22 Full Development Plan
Genencor currently plans to [ *** ]. An important success factor will be [ *** ]. A [
*** ] may be acceptable. [ *** ] is rapidly becoming the [ *** ] for [ ***
]. It may become advisable to conduct [ *** ], or [ *** ]. Future [ *** ] will depend on [
*** ]. The [ *** ] has accepted [ *** ]. Following completion of [ *** ], [ *** ] will be designed if warranted by [ *** ]. Again, the [
*** ] will be completed [ *** ], other [ *** ], and [ *** ]. Results from [ *** ] will also be used [ *** ]. BL22 Manufacturing Plan
The process used at [ *** ] for manufacturing [ *** ], while acceptable [ *** ], would not be
acceptable [ *** ]. An improved [ *** ]. Following technology transfer to Genencor, Genencor
plans to [ *** ]. Additional [ *** ]. BL22 DEVELOPMENT BENCHMARKS BENCHMARK
    
    
    COMPLETION[ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ]
 HA22 Development Plan HA22 Preclinical Development Plan
The initial preclinical program will provide support for [ *** ] and [ *** ]. GCOR plan an
extensive characterization [ *** ]. [ *** ] [ *** ] [ *** ] Preclinical Evaluation of HA22 for use in [ *** ]
The program [ *** ] to [ *** ]. Based on [ *** ]. HA22 Early Clinical Development Plan
When, following [ *** ], [ *** ] becomes available, an [ *** ] development plan will be
implemented in order to:  1.
    [ *** ],2.
    [ *** ],




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*** TEXT OMITTED AND FILED SEPARATELYCONFIDENTIAL TREATMENT REQUESTED  3.
    [ *** ],4.
    [ *** ]. [ *** ]. [ *** ]. HA22 Full Development Strategy
The full development strategy will [ *** ]. HA22 Manufacturing Plan
[ *** ] HA22 material beyond that [ *** ] being manufactured for [ *** ]. [ *** ]. HA22 DEVELOPMENT BENCHMARKS BENCHMARK
    
    
    COMPLETION[ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ][ *** ]
    
    
    [ *** ]
 Marketing and Sales Plan for BL22 and/or HA22 Genencor intends to establish [ *** ]. [ *** ].